Analytical method validation is a crucial part of formulation development. It is needed to ensure that methods provide accuracy and precision in detecting formulation differences in drug dissolution, ...

This article presents a simple and systematic approach to HPLC method development, beginning with sample preparation and finishing with practical analytical method validation. The wide variety of ...

This course provides a comprehensive coverage of the method development and validation requirements that are essential to progress a pharmaceutical compound, at each stage of product development. Upon ...

Although these technologies are emerging, data from similar molecules, for example of other serotypes in gene therapy, can be leveraged to support method development, validation, and specification ...

However, implementation can be daunting due to the complex nature of the instrumentation and the added burden of development and validation of methods that must be undertaken by the laboratory if they ...

DSI has an analytical development team with experience in comprehensive methods development and validation. DS InPharmatics (DSI) provides regulatory, technical, and project management consulting ...

Phase III – The analytical procedure may change again during this final phase of development as we look to optimize the method in preparation for process validation and long-term commercial use. An ...

analysis and validation and to assess its psychometric properties. Background To our knowledge, there is no patient-reported functional scale specific for acute hamstring injuries. Methods The ...

This course provides a comprehensive coverage of the method development and validation requirements that are essential to progress a pharmaceutical compound, at each stage of product development. Upon ...